Recruiting

Hearing Healthcare

Sponsor:

University of Alabama, Tuscaloosa

Code:

NCT04671381

Conditions

Hearing Loss

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Accepted

Interventions

Hearing Evaluation

Over-the-Counter Hearing Aid (OTC HA) Fitting and Orientation

Four Weeks of Aural Rehabilitation

Provision of Over-the-Counter Hearing Aids

Study Details

Brief summary:

This project will address quality of care issues associated with hearing loss in adults who have mild-to-moderate hearing loss and who have no access to hearing healthcare. Through the use of three different interventions involving over-the-counter hearing aids, it will lead to options that will increase access and affordability of hearing healthcare for adults with mild-to-moderate hearing loss.

Conditions

Hearing Loss

Study ID

NCT04671381

Start date

Jan 1, 2021

Status verified date

Oct, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Mild-to-moderate hearing loss
  • Live in West Central or South Alabama
  • 40 years of age or older

Exclusion Criteria:

• Medical conditions resulting in severe cognitive impairment (e.g., stroke, head injury, senile dementia or Alzheimer's disease)

Study Design

Enrollment

210 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Audiology Best Practices plus Aural Rehabilitation (ABP+AR)

This experimental group will receive a hearing evaluation, an over-the-counter hearing aid fitting and orientation, and four-weeks of an aural rehabilitation program conducted by specially-trained community health workers. Additionally, these adults will complete pre- and post-questionnaires and speech perception testing.

active comparator: Audiology Best Practices (ABP)

This comparison group of adults with hearing loss will receive a hearing evaluation and over-the-counter hearing aid fitting and orientation. The aural rehabilitation program will not be provided initially. These participants will complete pre- and post-questionnaires and speech perception testing.

active comparator: Over-the-Counter Only (OTC-Only)

This comparison group of adults with hearing loss will receive a hearing evaluation. They will be provided with over-the-counter hearing aids but the audiologist will not assist with fitting the aids or providing an orientation. This arm mimics what would happen when a consumer privately purchases over-the-counter hearing aids. They will complete pre- and post-questionnaires and speech perception testing.

Interventions

Hearing Evaluation

Behavioral thresholds for pure tones will be conducted along with speech perception measures.

Over-the-Counter Hearing Aid (OTC HA) Fitting and Orientation

Study participants will be fitted with binaural OTC HAs in addition to receiving information on how to use and care for their devices.

Four Weeks of Aural Rehabilitation

Participants will receive four weeks of information sessions to help them adjust to their over-the-counter hearing aid and their hearing loss.

Provision of Over-the-Counter Hearing Aids

Study participants will receive binaural OTC HAs. Participants will fit their OTC HAs based on manufacturer guidelines without the help of an audiologist.

Primary outcome measure

  • Measuring Change in the Hearing Handicap Inventory for Elderly (HHIE) Outcomes [ Time Frame: A baseline outcome will be obtained prior to over-the-counter hearing aid fitting. Outcomes will be measured at weeks 4 to 7 of intervention, during week 14 of the intervention, and through study completion, or 1 assessment each year. ]
  • Measuring Change in International Outcome Inventory for Hearing Aids (IOI-HA) Outcomes [ Time Frame: A baseline outcome will be obtained prior to over-the-counter hearing aid fitting. Outcomes will be measured at weeks 4 to 7 of intervention, during week 14 of the intervention, and through study completion, or 1 assessment each year. ]

Central Contacts and Locations

Central contacts

Marcia J Hay-McCutcheon, PhD

205-348-4572mhaymccu@ua.edu

Locations

The University of Alabama

Recruiting

Tuscaloosa, Alabama, United States, 35487

Contacts

Marcia J Hay-McCutchoen, PhD

205-348-4572mhaymccu@ua.edu

More Information

Sponsor

University of Alabama, Tuscaloosa

Last update posted

Oct 30, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama, Tuscaloosa on 2024-10-30.